What changed in this filing

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Item 1. Business

2025-03-24 compared with 2024-03-25 · 630 added, 448 removed, 598 unchanged (64% of the section changed)

Unless the context otherwise requires, “we”,

“us”, and “our”, the “Company” and “PAVmed” refer to PAVmed Inc.

and its subsidiaries,

including its subsidiary Lucid Diagnostics Inc.

(Nasdaq:LUCD) (“Lucid Diagnostics” or “Lucid”) and its majority-owned

subsidiary Veris Health Inc.

(“Veris Health” or “Veris”).

is structured to be a multi-product life sciences company organized to advance a pipeline of innovative healthcare technologies.

by a team of highly skilled personnel with a track record of bringing innovative products to market, PAVmed is focused on innovating,

developing, acquiring, and commercializing novel products that target unmet needs with large addressable market opportunities.

our corporate structure—a parent company that will establish distinct subsidiaries for each financed asset—we have the flexibility

to raise capital at the PAVmed level to fund product development, or to structure financing directly into each subsidiary in a manner

tailored to the applicable product, the latter of which is our current strategy given prevailing market conditions.

developing, acquiring, and commercializing novel products that target unmet medical needs with large addressable market opportunities.

Leveraging our corporate structure—a parent company that will establish distinct subsidiaries for each financed asset—we

have the flexibility to raise capital at the PAVmed level to fund product development, or to structure financing directly into each subsidiary

in a manner tailored to the applicable product.

current focus is multi-fold.

We continue to pursue commercial expansion and execution of EsoGuard, which is the flagship product of

our majority-owned subsidiary Lucid Diagnostics Inc.

LUCD) (“Lucid” or “Lucid Diagnostics”).

addition, through a separate majority-owned subsidiary, Veris Health Inc.

(“Veris” or “Veris Health”), we are focused on entering into

strategic partnership opportunities with leading academic oncology systems to expand access to the Veris Platform.

In terms of other

existing products and technologies, we have created an incubator-type platform where we are looking to obtain financing on a

product-by-product basis as necessary to advance each asset to a meaningful inflection point along its path to commercialization.

Finally, as resources permit, we will continue to explore external innovations that fulfill our project selection criteria without

limiting ourselves to any target sector, specialty or condition.

believe that the flagship product of our majority-owned subsidiary Lucid, the EsoGuard Esophageal DNA Test, performed on samples collected

with the EsoCheck Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of

serving as a widespread testing tool with the goal of preventing esophageal adenocarcinoma (“EAC”) deaths, through early

detection of esophageal precancer in at-risk gastroesophageal reflux disease (“GERD,” also commonly known as chronic heartburn,

acid reflux or simply reflux) patients.

We continue to support the commercial expansion and execution of EsoGuard, which is the flagship

product of our subsidiary Lucid Diagnostics, of which we remain the shareholder with the largest voting interest.

through a separate majority-owned subsidiary, Veris Health, we offer the Veris Cancer Care Platform.

We are focused in the immediate

term on entering into strategic partnership opportunities with leading academic oncology systems to expand access to the Veris

Cancer Care Platform, while concurrently developing an implantable physiological monitor, designed to be implanted alongside a

chemotherapy port, which will interface with the Veris Cancer Care Platform.

In terms of other existing products and technologies,

we have adopted an incubator-type platform where we are looking to obtain financing on a product-by-product basis as necessary to

advance each asset to a meaningful inflection point along its path to commercialization.

Finally, as resources permit, we will

continue to explore external innovations that fulfill our project selection criteria without limiting ourselves to any target

sector, specialty or condition.

believe that Lucid’s flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal

Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread testing

tool with the goal of preventing esophageal adenocarcinoma (“EAC”) deaths, through early detection of esophageal precancer

in at-risk gastroesophageal reflux disease (“GERD,” also commonly known as chronic heartburn, acid reflux or simply reflux)

is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck.

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patients recommended for screening by clinical practice guidelines.

(In December 2019, we secured “gapfill” determination

(In December 2019, Lucid secured “gapfill” determination

for EsoGuard’s PLA code 0114U through the CMS CLFS process.

This allowed us to engage directly with Medicare contractor Palmetto

This allowed Lucid to engage directly with Medicare contractor Palmetto

GBA and its MolDx Program on CMS payment and coverage.

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including the American College of Gastroenterology (“ACG”) BE Guidelines.

In its Recommendation 5, the ACG suggests a single screening

endoscopy in patients with chronic GERD symptoms and 3 or more additional risk factors for BE, including male sex, age greater than 50

years, White race, tobacco smoking, obesity, and family history of BE or EAC in a first-degree relative.

In its Recommendation 5, the ACG suggests a single

screening endoscopy in patients with chronic GERD symptoms and 3 or more additional risk factors for BE, including male sex, age greater

than 50 years, White race, tobacco smoking, obesity, and family history of BE or EAC in a first-degree relative.

ACG clinical guideline entitled “ Diagnosis and Management of Barrett’s Esophagus:

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For the first

time, however, the clinical guideline also endorses nonendoscopic biomarker screening as an acceptable alternative to costly and invasive

endoscopy stating that “a swallowable nonendoscopic capsule device combined with a biomarker is an acceptable alternative to endoscopy

for BE.” The clinical guideline specifically mentions EsoCheck, along with Lucid’s EsophaCap® device, as such swallowable,

nonendoscopic esophageal cell collection devices, as well as methylated DNA biomarkers such as EsoGuard.

The summary of evidence for

this recommendation includes a reference to the seminal NIH-funded, multicenter, case-control study published in 2018 in Science Translational

Medicine , which demonstrated that EsoGuard is highly accurate at detecting esophageal precancer and cancer, including on samples

collected with EsoCheck.

July 2022, the American Gastroenterology Association (“AGA”) published in their “Clinical Practice Update on New Technology

time, however, the clinical guideline also endorses non-endoscopic biomarker screening as an acceptable alternative to costly and invasive

endoscopy stating that “a swallowable non-endoscopic capsule device combined with a biomarker is an acceptable alternative to endoscopy

for BE.” The clinical guideline specifically mentions EsoCheck, as such swallowable, non-endoscopic esophageal cell collection

devices, as well as methylated DNA biomarkers such as EsoGuard.

The summary of evidence for this recommendation includes a reference

to the seminal NIH-funded, multicenter, case-control study published in 2018 in Science Translational Medicine , which demonstrated

that EsoGuard is highly accurate at detecting esophageal precancer and cancer, including on samples collected with EsoCheck.

July 2022, the AGA published in their “Clinical Practice Update on New Technology

and Innovation for Surveillance and Screening in Barrett’s Esophagus” updated clinical guidance that mirrors the same furnished

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recommended for screening.

In March 2025, Lucid announced that a recent update to the National Comprehensive Cancer Network® (NCCN) Clinical

Practice Guidelines in Oncology (NCCN Guidelines®) focused on Esophageal and Esophagogastric Junction Cancers (Version 1.2025) has

added a new section on BE screening.

The NCCN Guidelines® now reference professional society guidelines on BE screening, including

the most recent ACG clinical guideline discussed above, which recommends non-endoscopic biomarker testing, such as EsoGuard performed

on samples collected with EsoCheck, as an acceptable alternative to invasive upper endoscopy to detect esophageal precancer.

Commercialization

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treatment with endoscopic esophageal ablation.

assure sufficient testing capacity and geographic coverage, we have undertaken multiple ways for patients have access to our test.

we built a limited network of our own physical Lucid Test Centers, staffed by Lucid-employed clinical personnel, where patients can undergo

the EsoCheck procedure and have the sample sent for EsoGuard testing at Lucid’s CLIA-certified laboratory.

Our current test center

network currently includes locations in metropolitan areas in Arizona, California, Colorado, Florida, Idaho, Illinois, Nevada, Ohio,

Oregon, Texas and Utah.

addition to our own test center locations, we have broadened patient access to our test by establishing a satellite test center program,

whereby we are making our personnel available to perform cell collection services inside physician offices or in certain geographies,

assure sufficient testing capacity and geographic coverage, Lucid has undertaken multiple ways for patients to have access to its test.

Initially, Lucid built a limited network of its own physical Lucid Test Centers, staffed by Lucid-employed clinical personnel, where

patients can undergo the EsoCheck procedure and have the sample sent for EsoGuard testing at Lucid’s CLIA-certified laboratory.

Our current test center network currently includes locations in metropolitan areas in Arizona, California, Colorado, Florida, Georgia,

Idaho, Michigan, Nevada, Texas and Utah.

addition to our own test center locations, Lucid has broadened patient access to its test by establishing a satellite test center program,

whereby it is making its personnel available to perform cell collection services inside physician offices or in certain geographies,

closely nearby physician offices (in Florida, for the time being) by way of our Lucid Mobile Testing Unit.

in January 2023, we completed our first #CheckYourFoodTube Precancer Testing Event, with the San Antonio Fire Department (the

“SAFD”) during Firefighter Cancer Awareness Month as designated by the International Association of Fire Fighters

A total of 391 members who were deemed to be at-risk for esophageal precancer, underwent a brief, on-site, noninvasive cell

collection procedure, performed by our clinical personnel using EsoCheck.

Since then, additional testing events have been hosted

with the SAFD, and many similar events have been held with fire departments throughout the country.

These events are ongoing and are

an extension of Lucid’s satellite test center program, which brings our precancer testing directly to patients—at their

physician’s office and now at testing day events.

March 2023, we launched a Direct Contracting Strategic Initiative (“DCSI”) to engage directly with large Administrative Services

Only (“ASO”) self-insured employers, unions and other entities, seeking to replicate the successes of other cancer screening

diagnostic companies that have deployed similar strategies.

In August 2023, we contracted with the Ancira Automotive

Group as a result of this initiative, providing access to esophageal precancer testing for its employees at all 12 San Antonio locations.

have also established an EsoGuard Telemedicine Program, in partnership with UpScript, LLC, an independent third-party telemedicine provider,

in January 2023, Lucid completed its first #CheckYourFoodTube Precancer Testing Event, with the San Antonio Fire Department (the “SAFD”)

during Firefighter Cancer Awareness Month as designated by the International Association of Fire Fighters (IAFF).

A total of 391 members

who were deemed to be at-risk for esophageal precancer, underwent a brief, on-site, noninvasive cell collection procedure, performed

by Lucid’s clinical personnel using EsoCheck.

Since then, additional testing events have been hosted with the SAFD, and many similar

events have been held with fire departments throughout the country.

These events are ongoing and are an extension of Lucid’s satellite

test center program, which brings Lucid’s precancer testing directly to patients—at their physician’s office and now

at testing day events.

March 2023, Lucid launched a direct contracting strategic initiative to engage directly with large Administrative Services Only (“ASO”)

self-insured employers, unions and other entities, seeking to replicate the successes of other cancer screening diagnostic companies

that have deployed similar strategies.

January 2025, Lucid expanded on its direct contracting initiative by launching a cash-pay program targeting concierge medicine, as an

important component of its strategic efforts to expand its contractually-guaranteed revenue.

Lucid has already contracted with several

concierge medicine practices under this initiative.

has also established an EsoGuard Telemedicine Program, in partnership with UpScript, LLC, an independent third-party telemedicine provider,

that accommodates EsoGuard self-referrals from direct-to-consumer marketing.

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and Market Access

noted above, in December 2019, we secured “gapfill” determination for EsoGuard’s PLA code 0114U through the CMS CLFS

This allowed us to engage directly with Medicare contractor Palmetto GBA and its MolDx Program on CMS payment and coverage.

noted above, in December 2019, Lucid secured “gapfill” determination for EsoGuard’s PLA code 0114U through the CMS

CLFS process.

This allowed Lucid to engage directly with Medicare contractor Palmetto GBA and its MolDx Program on CMS payment and coverage.

In October 2020, CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective January 1, 2021.

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test has fulfilled all these criteria, it indicated that it will “monitor the evidence and may revise this determination based

on the pertinent literature and society recommendations.” We expect to submit EsoGuard for Technical Assessment under this foundational

LCD later this year.

parallel with preparing to submit EsoGuard for Technical Assessment with MolDX, Lucid is aggressively pursuing EsoGuard commercial insurer

payment and coverage.

Although the claim adjudication cycle can be prolonged during the early commercialization of a new test, Lucid

has received and continues to receive out-of-network commercial insurance payments for the EsoGuard test, which accounts for the vast

majority of our revenue to date.

Additionally, the legislatures in

a number of states have passed laws mandating coverage of comprehensive biomarker testing over the past several years.

We believe that

EsoGuard falls within the definition of a biomarker test and thus we are reviewing how to leverage legislation in those states to expand

access to EsoGuard.

on the pertinent literature and society recommendations.” In November 2024, Lucid submitted to MolDx its complete clinical evidence

package in support of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard.

parallel with our request for reconsideration of the LCD, Lucid is aggressively pursuing EsoGuard commercial insurer coverage and payment.

Although the claim adjudication cycle can be prolonged during the early commercialization of a new test, Lucid has received and continues

to receive out-of-network commercial insurance payments for the EsoGuard test, which accounts for the vast majority of our revenue to

Additionally,

the legislatures in a number of states have passed laws mandating coverage of comprehensive biomarker testing over the past several years.

Lucid believes that EsoGuard falls within the definition of a biomarker test and thus Lucid is reviewing how to leverage legislation

in those states to expand access to and reimbursement of EsoGuard.

Utility and Clinical Trials

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physician understanding of test indications and potential benefit to the patients.

continues to expand the EsoGuard and EsoCheck evidence portfolio with additional clinical utility, clinical validity, and analytical

validity data from a range of ongoing studies and those that have recently completed or will be completed in the upcoming year.

efforts include planned publication of the results from the previously discussed “Multi-center, Single-arm EsoGuard clinical validation

study” (“BE-1”) which will also be presented at Digestive Disease Week (DDW) 2024;

this third clinical validation study

evaluated EsoGuard performance in the intended-use population.

Publication of real-world experience of EsoCheck as a nonendoscopic cell

collection device is also planned (previously presented as a poster at DDW 2023), in addition to results from EsoGuard analytical validation

studies performed by LucidDx Labs, and a summary of real-world outcomes from several hundred patients who tested positive with EsoGuard

and underwent confirmatory endoscopic evaluation.

These four manuscripts will be submitted for peer review in the first half of 2024.

Lucid-sponsored multi-center, prospective, observational CL inical U tility of E soGuard study ( CLUE ) with >500

subjects completed enrollment in late 2023, and full results are expected to be published in mid-2024;

results from an additional data

snapshot of the Lucid-sponsored PREVENT and PREVENT - F ire f ighter ( FF ) registries with a combined enrollment

of >1,000 subjects are expected to be published in a similar timeframe.

Both studies capture information on the diagnostic and/or

therapeutic journey of subjects following EsoGuard testing, and in addition to provider decision impact, will contribute differing levels

of clinical outcomes data to the Lucid evidence portfolio.

results for the Lucid-sponsored virtual-patient study are expected to be ready for analysis in mid-2024.

the “EsoGuard case-control study” (“BE-2”), a Lucid-sponsored clinical validation study, resumed enrollment in

2023 and is expected to continue through 2024.

This data will further supplement what has previously been produced by the two NCI-funded

studies (Moinova, et al.

Sci Transl Med.

continues to expand the EsoGuard and EsoCheck evidence portfolio with additional clinical utility and clinical validity data from a range

of ongoing studies and those that will be completed in the upcoming year.

These efforts include completion of the ESOGUARD-BE2 study,

a large multi-center case control study recruiting patients from large academic institutions in the Netherlands and across the U.S.,

in the first half of the year and submission for peer review of a publication of the results in the second half of 2025.

This data will

further supplement what has previously been published from the four earlier clinical validation studies from Moinova et.

(2024), Greer et.

al., (2024), and Shaheen et.

A large, nearly 12,000 patient real-world experience of EsoCheck

and EsoGuard from 18 months of commercial data is expected to be submitted for peer review publication in the first half of the year.

Finally, data accrual from the PREVENT and PREVENT-FF registries remains ongoing.

Both registries capture information on the diagnostic

and/or therapeutic journey of subjects following EsoGuard testing, and in addition to provider decision impact, will contribute differing

levels of clinical outcomes data to the Lucid evidence portfolio.

Manufacturing

is currently manufactured for us by our partners Coastline International (“Coastline”), a high-volume device manufacturer,

and Sage Product Development.

Our current line at Coastline can produce up to 25,000 units per year.

is currently manufactured for Lucid by Coastline International (“Coastline”), a high-volume device manufacturer, and Sage

Product Development.

Lucid’s current line at Coastline can produce up to 25,000 units per year.

With Coastline’s improvement

and expansion, there is capacity to scale exponentially.

Our EsoGuard Specimen Kits are currently manufactured for us by our partner

The warehousing, logistics, fulfillment and customer support of our products is managed for us by our partners HealthLink International

(a leading third-party logistics company) and Path-Tec.

Lucid’s EsoGuard specimen kits are currently manufactured by Path-Tec.

Path-Tec also manages warehousing, logistics, fulfillment and customer support of Lucid’s products.

the terms of Lucid’s license agreement with CWRU (as amended to date, the “Amended CWRU License Agreement”), Lucid

acquired an exclusive worldwide right to use the intellectual property rights to the EsoGuard and EsoCheck technology for the

detection of changes in the esophagus and on sample preservation.

Lucid is required to pay CWRU royalties on net sales of licensed

products as follows:

acquired an exclusive worldwide right to use the intellectual property rights to the EsoGuard and EsoCheck technology for the detection

of changes in the esophagus and on sample preservation.

Lucid is required to pay CWRU royalties on net sales of licensed products as

5% of net sales of less than $100 million per year;

and 8% of net sales greater than $100 million per year.

Lucid is also required to pay CWRU minimum annual royalty payments as follows:

$50,000 per year, beginning January 1 following the

first anniversary of a commercial sale of a licensed product;

$150,000 per year, if net sales of a licensed product exceed $25

million in a year;

Lucid is also required

to pay CWRU minimum annual royalty payments as follows:

$50,000 per year, beginning January 1 following the first anniversary of a commercial

sale of a licensed product;

$150,000 per year, if net sales of a licensed product exceed $25 million in a year;

and $600,000 per year, if net

sales of a licensed product exceed $100 million in a year.

Minimum yearly royalty amounts are subject to increase based on the

percentage change in the CPI-W Consumer Price Index and are credited against the royalties otherwise due.

The license agreement was

subject to four regulatory and commercialization milestones, of which one remains unachieved and unpaid.

The remaining milestone is

the FDA PMA submission of a licensed product, upon the achievement of which we will pay CWRU a milestone payment of $200,000.

license agreement terminates upon the expiration of the last-to-expire licensed patent, or on May 12, 2038, in countries where no

such patents exist, or upon expiration of any exclusive marketing rights for a licensed product that have been granted by FDA or

$300,000 per year, if

net sales of a licensed product exceed $50 million in a year;

and $600,000 per year, if net sales of a licensed product exceed $100 million

Minimum yearly royalty amounts are subject to increase based on the percentage change in the CPI-W Consumer Price Index and

are credited against the royalties otherwise due.

The license agreement was subject to four regulatory and commercialization milestones,

of which one remains unachieved and unpaid.

The remaining milestone is the FDA PMA submission of a licensed product, upon the achievement

of which we will pay CWRU a milestone payment of $200,000.

The license agreement terminates upon the expiration of the last-to-expire

licensed patent, or on May 12, 2038, in countries where no such patents exist, or upon expiration of any exclusive marketing rights for

a licensed product that have been granted by FDA or other U.S.

government agency, whichever comes later.

June 2019, we received FDA 510(k) clearance to market EsoCheck in the U.S.

June 2019, Lucid received FDA 510(k) clearance to market EsoCheck in the U.S.

as a device indicated for use in the collection and retrieval

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populations in the U.S.

In December 2019, our CLIA-certified then-laboratory partner, completed documentation of EsoGuard analytical

validity allowing us to commercialize it as a LDT.

February 2020, we received FDA “Breakthrough Device Designation” for EsoGuard as an in-vitro diagnostic (“IVD”)

In December 2019, Lucid’s CLIA-certified then-laboratory partner, completed documentation of EsoGuard analytical

validity allowing Lucid to commercialize it as a LDT.

February 2020, Lucid received FDA “Breakthrough Device Designation” for EsoGuard as an in-vitro diagnostic (“IVD”)

medical device.

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more favorable pre/post market data collection balance.

The Centers for Medicare and Medicaid Services and the United States Congress

continue to work to provide an expedited coverage pathway for emerging technologies.

May 2021, we received CE Mark certification for EsoCheck (under the Medical Devices Directive 93/42/EEC), and in June 2021, we completed

CE Mark self-certification for EsoGuard (under the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC)), indicating both may

be marketed in CE Mark European countries.

May 2021, Lucid received CE Mark certification for EsoCheck (under the Medical Devices Directive 93/42/EEC), and in June 2021, Lucid

completed CE Mark self-certification for EsoGuard (under the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC)), indicating

both may be marketed in CE Mark European countries.

October 2023, FDA proposed a policy under which FDA intends to phase out its general enforcement discretion approach for LDTs so that

IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs.

If finalized, FDA believes

that this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance

of safety and effectiveness.

As such, FDA has structured the proposed phaseout policy to contain five key stages:

End the general enforcement discretion approach with respect to Medical Device Regulation (MDR) requirements and correction and

removal reporting requirements 1 year after FDA publishes a final phaseout policy, which FDA intends to issue in the preamble of

the final rule.

End the general enforcement discretion approach with respect to requirements other than MDR, correction and removal reporting,

Quality System (QS), and premarket review requirements 2 years after FDA publishes a final phaseout policy.

End the general enforcement discretion approach with respect to QS requirements 3 years after FDA publishes a final phaseout policy.

End the general enforcement discretion approach with respect to premarket review requirements for high-risk IVDs 3.5 years after

FDA publishes a final phaseout policy, but not before October 1, 2027.

End the general enforcement discretion approach with respect to premarket review requirements for moderate risk and low risk IVDs

(that require premarket submissions) 4 years after FDA publishes a final phaseout policy, but not before April 1, 2028.

is currently anticipated that FDA will finalize the proposed policy by April 2024.

Once the final policy is released, we will implement

the QS requirements in the recommended staged approach and conduct pre-submission meetings with FDA to seek agreement on regulatory pathway

for EsoGuard premarket submission.

As required by the final policy, we will submit the regulatory premarket submission to the FDA as

per the timeframe defined in the final policy.

We are confident that the proposed policy will not have a commercial impact as the Company

already has a robust QS management platform for medical devices and EsoGuard will be able to transition to the platform to fulfill the

QS requirements, if and when required by the FDA.

On May 6, 2024, the FDA issued

a final rule aimed at helping to ensure the safety and effectiveness of LDTs.

The rule amends the FDA’s regulations to make explicit

that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”), including when the manufacturer of the IVD

is a laboratory.

Along with this amendment, the FDA is finalizing a policy under which the FDA will provide greater oversight of IVDs

offered as LDTs through a phaseout of its general enforcement discretion approach for LDTs over the course of four years, as well as

targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.

phaseout policy contains the following five stages:

Beginning on May 6, 2025, which is one year after the publication date of the final LDT rule, FDA will expect compliance with

medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements

regarding complaint files.

Beginning on May 6, 2026, which is 2 years after the publication date of the final LDT rule, FDA will expect compliance with requirements

not covered during other stages of the phaseout policy, including registration and listing requirements, labeling requirements, and

investigational use requirements.

Beginning on May 6, 2027, which is 3 years after the publication date of the final LDT rule, FDA will expect compliance with QS

requirements (other than requirements regarding complaint files which are already addressed in stage 1).

Beginning on November 6, 2027, which is 3½ years after the publication date of the final LDT rule, FDA will expect compliance

with premarket review requirements for high-risk IVDs offered as LDTs (IVDs that may be classified into class III or that are subject

to licensure under section 351 of the Public Health Service Act), unless a premarket submission has been received by the beginning

of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.

Beginning on May 6, 2028, which is 4 years after the publication date of the final LDT rule, FDA will expect compliance with premarket

review requirements for moderate-risk and low-risk IVDs offered as LDTs (that require premarket submissions), unless a premarket

submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion

for the pendency of its review.

FDA also intends to exercise enforcement discretion and generally not enforce some or all applicable requirements for certain categories

of IVDs manufactured by a laboratory.

The categories of enforcement discretion that are applicable to EsoGuard are summarized in the

4 & 5 (Premarket Review)

marketed IVDs offered as LDTs first marketed prior to rule publication date and not modified beyond scope described in preamble Section

V.B.3 of preamble

generally expected beginning May 6, 2025

generally expected beginning May 6, 2026

with 21 CFR 820.180-820.186 generally expected beginning May 6, 2027;

generally not expected with other QS requirements (except for complaint files)

generally not expected

approved by NYS CLEP Section V.B.2 of preamble

generally expected beginning May 6, 2025

generally expected beginning May 6, 2026

generally expected beginning May 6, 2027

generally not expected

EsoGuard was marketed prior to rule publication and is also NYS CLEP approved, hence, enforcement discretion is applicable for

compliance with Stages 4 and 5.

We will be implementing compliance with MDR requirements, correction and removal reporting

requirements, and quality system (QS) requirements regarding complaint files by March 31, 2025, well before the deadline of May 6,

Gap analysis has been completed and we are expecting our compliance activities to be completed for Stages 2 and 3 before the FDA’s expected timeframes in 2026 and 2027, respectively.

confident that the proposed final rule will not have a commercial impact as the Company already has a robust QS management platform

for medical devices and EsoGuard will be able to easily transition to the platform to fulfill the QS requirements, as required by

longer-term strategy is to secure a specific indication, based on published guidelines, for BE testing in certain at-risk populations

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approved by the FDA as an IVD device.

February 25, 2022, our new, wholly owned subsidiary, LucidDx Labs Inc.

(“LucidDx Labs”), acquired from ResearchDx Inc.

(“RDx”), certain licenses and other related assets necessary for LucidDx Labs to operate its own new CLIA-certified,

CAP-accredited clinical laboratory located in Lake Forest, CA.

Since March 2022, we have conducted EsoGuard testing at our own

laboratory with, until February 10, 2023, the assistance of RDx, which had continued to provide certain testing and related services

for the laboratory in accordance with the terms of a management services agreement (“MSA RDx”).

LucidDx Labs and RDx

agreed to terminate the MSA RDx effective as of February 10, 2023, such that LucidDx Labs now operates the laboratory itself, which

the Company believes has improved the efficiency of the performance of the EsoGuard assay.

February 25, 2022, a newly-formed wholly owned subsidiary of Lucid, LucidDx Labs Inc.

(“LucidDx Labs”), acquired from ResearchDx

(“RDx”), certain licenses and other related assets necessary for LucidDx Labs to operate its own new

CLIA-certified, CAP-accredited clinical laboratory located in Lake Forest, CA.

Since March 2022, Lucid has conducted EsoGuard

testing at its own laboratory.

November 2023, LucidDx Labs launched EsoGuard 2.0, which uses multiplexing thereby allowing both genes to be interrogated on a single

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than 30 million at-risk individuals over the age of 50.

Given the large market for pre-cancer testing, we likely will face numerous competitors,

some of which possess significantly greater financial and other resources and development capabilities than us.

Our EsoGuard test faces

competition from procedure-based detection technologies such as upper endoscopy, and other testing technologies such as multi-cancer

Given the large market for pre-cancer testing, Lucid likely will face numerous

competitors, some of which possess significantly greater financial and other resources and development capabilities than Lucid.

test faces competition from procedure-based detection technologies such as upper endoscopy, and other testing technologies such as multi-cancer

early detection products.

Our EsoCheck device faces competition from other manufactures with devices designed to collect cell samples

The EsoCheck device faces competition from other manufacturers with devices designed to collect cell samples

from targeted regions of the esophagus.

For example, EndoSign, commercialized by Cyted, and much like Cytosponge and our own EsophaCap

before it, is a small mesh sponge within a soluble gelatin capsule that needs to reside in the stomach and then is pulled thru the targeted

region brushing the lining of the esophagus and then later retrieved, although, unlike EsoCheck, it is unprotected from sample contamination

as the brush later passes regions of the upper esophagus and mouth.

Our competitors may also be developing additional methods of detecting

esophageal cancer and pre-cancer that have not yet been announced.

of our existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing and technological

We may be unable to compete effectively against our competitors either because their products and services are superior or

more cost efficient, or because they have access to greater resources than us.

These competitors may have greater name recognition

Many of these competitors have obtained all desirable FDA or other regulatory approvals, and superior patent protection,

for their products.

Certain of our competitors have already commercialized their products, and others may commercialize their products

in advance of our products.

In addition, our competitors may make technical advances that render our products obsolete.

We may be unable

to respond to such technical advances.

For example, EndoSign, commercialized by Cyted, and much like Cytosponge, is a small mesh sponge

within a soluble gelatin capsule that needs to reside in the stomach and then is pulled thru the targeted region brushing the lining

of the esophagus and then later retrieved, although, unlike EsoCheck, it is unprotected from sample contamination as the brush later

passes regions of the upper esophagus and mouth.

Lucid’s competitors may also be developing additional methods of detecting esophageal

cancer and pre-cancer that have not yet been announced.

of Lucid’s existing and potential competitors have substantially greater financial, marketing, sales, distribution, manufacturing

and technological resources.

Lucid may be unable to compete effectively against our competitors either because their products and services

are superior or more cost efficient, or because they have access to greater resources than Lucid.

These competitors may have greater

name recognition than Lucid does.

Many of these competitors have obtained all desirable FDA or other regulatory approvals, and superior

patent protection, for their products.

Certain of Lucid’s competitors have already commercialized their products, and others may

commercialize their products in advance of Lucid’s products.

In addition, Lucid’s competitors may make technical advances

that render Lucid’s products obsolete.

Lucid may be unable to respond to such technical advances.

May 2021, we formed Veris Health, a majority-owned subsidiary, focused on digital health technology.

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care through remote monitoring and data analytics.

was founded in 2018 by experienced physician entrepreneurs, James Mitchell, M.D., who joined Veris Health as its full-time Chief Medical

Officer, and Andrew Thoreson, M.D., who serves as a Veris Health consultant.

They previously co-founded Redsmith, Inc., an interventional

catheter company whose technology was acquired by C.R.

Bard Inc., now BD Inc.

Oncodisc received a National Science Foundation

(“NSF”) Small Business Innovation Research (“SBIR”) grant award to support its early work and completed both

the MedTech Innovator Accelerator and UCSF Rosenman Institute Accelerator programs.

Veris Platform is a digital cancer care platform with physiologic data collection, symptom reporting and telehealth functions, designed

to improve personalized cancer care through remote patient monitoring.

Cancer patients enrolled in the Veris Platform receive a VerisBox™

with Veris-branded Bluetooth enabled connected health care devices.

The devices transmit clinical data to cancer care teams to detect

early signs of common cancer-related complications, provide longitudinal trends of physiologic and clinical data, and offer data-driven

risk management tools for precision oncology.

The Veris Platform integrates directly with practices’ and systems’ Electronic

Health Record (“EHR”) systems, allowing care teams to easily view and interact with this data.

We have also been developing

a groundbreaking implantable physiologic monitor containing biologic sensors capable of generating continuous data on key physiologic

parameters known to predict adverse outcomes in cancer patients undergoing treatment and as resources permit, we will resume further

development activities for the implantable to bring it to market.

The implantable will seamlessly interact with the Veris Platform.

technologies are the subject of multiple patent applications and one issued patent.

Health’s lead product, the Veris Cancer Care Platform, is a comprehensive digital cancer care platform with remote physiological

data collection, symptom reporting, telehealth capability and electronic health record (“EHR”) integration.

The platform offers enhanced

personalized cancer care through the early detection of complications, reduced unplanned hospitalizations, the provision of longitudinal

trends of physiological and clinical data, data-driven risk management tools, and increased patient and provider satisfaction.

patients enrolled on the platform receive a VerisBox™ of Veris-branded connected health care devices which transmit physiologic

data to the cloud-based clinician portal via embedded cellular connections.

A complementary patient portal enables patients to report

symptoms, as well as general health and quality of life parameters, to their cancer care team through the Veris patient smartphone app.

The app also allows caretakers and family members to follow along on the patient’s cancer care journey.

Veris is developing an

implantable physiological monitor, designed to be implanted alongside a vascular access port, which will interface with the Veris Cancer

Care Platform.

The implantable monitor will further enhance the clinical and commercial value of the platform by providing remote physiologic

data independent of patient compliance.

2024, approximately 2.0 million people in the U.S.

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market opportunity exceeds $2 billion.

In the future, we believe this opportunity will only expand through the implantable physiologic

monitor, data commercialization, and the expansion into other markets aside from oncology.

In the future, we believe this will only expand through the implantable physiologic monitor,

as well as other opportunities or enhancements Veris may pursue as resources permit, such as data commercialization, incorporating additional

AI-based features and the expansion into other markets aside from oncology.

Commercialization/Sales

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solution for these institutions’ oncology departments.

More broadly, in terms of our commercialization strategy, we have a software-as-a-service

recurring-revenue business model where we seek to generate recurring revenue through oncology practice and hospital-based subscriptions.

These entities pay monthly fees for each patient on the platform, through which they are able to derive revenues from remote physiologic

monitoring (and, in the future, device implantation) under existing CPT codes.

Veris also plans to build a commercialization model around

the oncology data it is collecting, as resources permit.

We have identified multiple potential use cases across a number of verticals,

including clinical trials, commercial use cases, and as a means to improve patient care.

To this end, Veris and The Ohio State University Comprehensive Cancer Center

- The James Cancer Hospital and Solove Research Institute (OSUCCC – The James), a National Cancer Institute-Designated Comprehensive

Cancer Center, executed a memorandum of understanding to implement a pilot program where cancer patients would be enrolled on the Veris

Cancer Care Platform™.

The pilot program was launched in June 2024, and has been extended through the end of March 2025.

This collaboration

represents a significant step forward in Veris Health’s commercialization strategy, allowing the company to demonstrate the value

of its platform and gather data on its effectiveness in improving personalized cancer care.

is continuing to pursue similar partnerships with other leading institutions.

Veris has a software-as-a-service recurring-revenue business

model, where it seeks to generate recurring revenue through oncology practice and hospital-based subscriptions.

These entities pay monthly

fees for each patient on the platform, through which they are able to derive revenues from remote physiologic monitoring (and, in the

future, device implantation) under existing CPT codes.

Veris also plans to build a commercialization model around the oncology data it

is collecting, as resources permit.

We have identified multiple potential use cases across a number of verticals, including clinical

trials, commercial use cases, and as a means to improve patient care.

Manufacturing

components comprising the Veris Platform are currently supplied to us by our partners TransTek and their U.S.-based subsidiary, Mio Labs.

components comprising the Veris Cancer Care Platform are currently supplied to us by our partners TransTek and their U.S.-based

subsidiary, Mio Labs.

Each has passed a SOC-2 audit by an outside auditor.

The final packaging of the overall box and order fulfillment is managed by PAVmed

at its Foxborough, MA location.

Customer support is currently managed internally, while partnering with Zendesk for customer service

Veris Platform software is considered a non-device Medical Device Data System (“MDDS”) that is excluded from the statutory

definition of a medical device under the FDC Act and as confirmed in the FDA’s MDDS Guidance:

Medical Device Data Systems, Medical

Image Storage Devices, and Medical Image Communications Devices.

Therefore, the Veris Platform is not subject to the FDA’s regulatory

requirements for devices.

The final packaging of the overall box and order

fulfillment is managed by PAVmed at its Foxborough, MA location.

Customer support is currently managed internally, while partnering

with Zendesk for customer service management.

Veris Cancer Care Platform qualifies as a Non-Device Clinical Decision Software (“CDS”) that is excluded from the

definition of a medical device under the FDCA, as amended by the 21st Century Cures Act, and therefore is not subject to the

FDA’s regulatory requirements for devices, as confirmed in the FDA’s Clinical Decision Support Software

Health is also developing an implantable cardiac monitor and is currently interacting with the FDA via pre-submission process, seeking

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of which possess significantly greater financial and other resources and development capabilities than us.

Our Veris Platform faces competition

from other digital care platforms providing many of the same features, including EHR integration and remote patient monitoring capabilities.

While we are not aware of other implantable physiologic monitors containing biologic sensors, our competitors may also be developing

similar devices that have not yet been announced.

On March 21, 2024, the Company announced

that it has launched a wholly owned incubator, PMX, to complete development and commercialization of existing portfolio technologies,

including PortIO, EsoCure and CarpX.

PMX and Hatch Medical, L.L.C.

(“Hatch Medical”), a medical device incubator and technology

brokerage firm, have executed a joint venture agreement to advance the technologies.

Pursuant to the joint venture agreement,

PAVmed will assign PortIO, EsoCure and CarpX to its wholly owned incubator, PMX.

Starting with PortIO, the Company will seek to independently

finance a separate subsidiary of the incubator to develop and commercialize each technology.

Hatch Medical will provide strategic advisory

and brokerage services to the subsidiary to advance the technology through key milestones and, subsequently, seek to engage a strategic

partner to acquire, license or distribute the commercial product.

Although the incubator, PMX, may seek to expand its portfolio

with internal or externally sourced technologies in the future, its initial assets, as noted, will include the following products:

Our Veris Cancer Care

Platform faces competition from other digital care platforms providing many of the same features, including EHR integration and

remote patient monitoring capabilities.

While we are not aware of other implantable physiologic monitors containing biologic

sensors, our competitors may also be developing similar devices that have not yet been announced.

March 21, 2024, PAVmed announced that it had launched a wholly owned incubator, PMX, to complete development and commercialization

of existing portfolio technologies, including PortIO, EsoCure and CarpX.

Although PMX may seek to expand its portfolio with internal

or externally sourced technologies in the future, its initial assets will include the following products:

PortIO implantable intraosseous vascular access device is being developed as a means for infusing fluids, medications and other substances

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or radiographic confirmation.

connection with our efforts to expand our presence in the EAC diagnostic market, we were developing the EsoCure Esophageal Ablation

Device, with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer,

and to do so without the need for complex and expensive capital equipment.

We have successfully completed a pre-clinical feasibility

animal study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining.

connection with our efforts to expand our presence in the EAC diagnostic market, we were developing the EsoCure Esophageal Ablation Device,

with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer, and to

do so without the need for complex and expensive capital equipment.

We have successfully completed a pre-clinical feasibility animal

study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining.

An acute and survival

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is a patented, single-use, disposable, minimally invasive surgical device for use in the treatment of carpal tunnel syndrome.

CarpX is designed to allow the physician to relieve the compression on the median nerve without an open incision or the need for endoscopic

or other imaging equipment, and therefore will be significantly less invasive than existing treatments.

To use CarpX, the operator first

advances a guidewire through the carpal tunnel under the ligament, and then advanced over the wire and positioned in the carpal tunnel

under ultrasonic and/or fluoroscopic guidance.

When the CarpX balloon is inflated it creates tension in the ligament positioning the

cutting electrodes underneath it and creates space within the tunnel, providing anatomic separation between the target ligament and critical

structures such as the median nerve.

Radiofrequency energy is briefly delivered to the electrodes, rapidly cutting the ligament, and

relieving the pressure on the nerve.

We believe CarpX will be significantly less invasive than existing treatments.

is designed to allow the physician to relieve the compression on the median nerve without an open incision or the need for

endoscopic or other imaging equipment, and therefore we believe it will be significantly less invasive than existing treatments.

use CarpX, the operator first advances a guidewire through the carpal tunnel under the ligament, and then advanced over the wire and

positioned in the carpal tunnel under ultrasonic and/or fluoroscopic guidance.

When the CarpX balloon is inflated it creates tension

in the ligament positioning the cutting electrodes underneath it and creates space within the tunnel, providing anatomic separation

between the target ligament and critical structures such as the median nerve.

Radiofrequency energy is briefly delivered to the

electrodes, rapidly cutting the ligament, and relieving the pressure on the nerve.

We believe CarpX will be significantly less

invasive than existing treatments.

received FDA 510(k) marketing clearance in April 2020, with the first commercial procedure successfully performed in December 2020.

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continue to pursue that project, as resources permit.

Z Warrant Modification

December 4, 2023, the Company announced the extension of the Company’s Series Z Warrants, by 12 months, to April 30, 2025.

In addition, as a

result of the reverse stock split, described below, the Series Z Warrants became exercisable to purchase one whole share of common

stock of the Company at an exercise price of $24.00, which exercise price per whole share was further reduced to $23.48 as described

below under the heading “ PAVmed Distribution of Lucid Diagnostics Common Stock to Shareholders ”.

recognized the incremental value associated with the Series Z Warrants modification for the term extension as a deemed dividend

charge of $1.8 million and as an increase of net loss available to common stockholders on the consolidated statements of operations

December 7, 2023, the Company implemented a 1-for-15 reverse stock split of its common stock and reduced its authorized shares from 250,000,000

to 50,000,000, each in accordance with shareholder approval granted at a March 31, 2023 special meeting of the Company’s stockholders.

The Company filed an amended Certificate of Incorporation reflecting the reduction in authorized shares.

purpose of the reverse stock split was to regain compliance with the $1 minimum bid price requirement for continued listing on the Nasdaq

Capital Market.

Indeed, on January 7, 2024, the Company received a letter from the Listing Qualifications Department of Nasdaq, stating

the Company had regained compliance with such requirement.

Services Agreement/Payroll Benefits and Expense Reimbursement Agreement with Lucid Diagnostics

On March 22, 2024, PAVmed and Lucid

entered into an eighth amendment to the management services agreement between PAVmed and Lucid (“MSA”) to increase the monthly

fee thereunder from $0.75 million per month to $0.83 million per month, effective as of January 1, 2024.

The amendment also reset the

maximum number of shares issuable under the agreement to 19.99% of the shares outstanding as of the date of the amendment.

January 26, 2024, in accordance with the MSA and the payroll, benefits and expense reimbursement agreement between PAVmed and Lucid (“PBERA”),

PAVmed elected to receive payment of approximately $4.7 million of fees and reimbursements accrued under the MSA and the PBERA through the issuance of 3,331,771 shares of Lucid’s common stock.

Distribution of Lucid Diagnostics Common Stock to Shareholders

February 15, 2024, the Company distributed by special dividend to the Company stockholders 3,331,747 shares of Lucid Diagnostics common

stock held by the Company.

On such date, each PAVmed shareholder as of the January 15,

2024 record date received a stock dividend of approximately 38 shares of Lucid common stock for every 100 shares of PAVmed common stock

they held as of such date.

The shares distributed were approximately equal to the number of shares of common stock that Lucid issued

to PAVmed on or about January 26, 2024 in satisfaction of certain intercompany obligations due to Lucid from PAVmed, as discussed above.

distribution constituted an “Extraordinary Dividend” as defined in the warrant agreement that governs the Company’s

Series Z Warrants.

As a result, pursuant to the warrant agreement, the exercise price under the Series Z Warrants per full share of PAVmed

common stock was automatically decreased by $0.52 (the fair market value of 0.37709668 of a share of Lucid Diagnostics’ common

stock) to $23.48 per share.

March 7, 2024, the Company received a notice from the Nasdaq Listing Qualifications Department stating that, for the preceding 30 consecutive

business days (through March 6, 2024), the market value of the Company’s listed securities (“MVLS”) had been below

the minimum of $35 million required for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2).

The notification

letter stated that the Company would be afforded 180 calendar days (until September 3, 2024) to regain compliance.

In order to regain

compliance, the Company’s MVLS must close at $35 million or more for a minimum of ten consecutive business days.

The notification

letter also states that in the event the Company does not regain compliance prior to the expiration of the 180-day period, the Company

will receive written notification that its securities are subject to delisting.

The Nasdaq notification has no effect at this time on

the listing of the Company’s common stock or Series Z warrants, and the stock and warrants will continue to trade uninterrupted

under the symbol “PAVM” and “PAVMZ”, respectively.

Incubator Program

On March 21, 2024, the Company announced

that it has launched a wholly owned incubator, PMX, to complete development and commercialization of existing portfolio technologies,

including PortIO, EsoCure and CarpX.

PMX and Hatch Medical, L.L.C.

(“Hatch Medical”), a medical device incubator and technology

brokerage firm, have executed a joint venture agreement to advance the technologies.

Pursuant to the joint venture agreement,

PAVmed will assign PortIO, EsoCure and CarpX to its wholly owned incubator, PMX.

Starting with PortIO, the Company will seek to independently

finance a separate subsidiary of the incubator to develop and commercialize each technology.

Hatch Medical will provide strategic advisory

and brokerage services to the subsidiary to advance the technology through key milestones and, subsequently, seek to engage a strategic

partner to acquire, license or distribute the commercial product.

Purchase Agreement - March 31, 2022 - Senior Secured Convertible Note - April 4, 2022 and Senior Secured Convertible Note - September

Effective as of March 12, 2024,

the Company entered into an amendment and waiver (the “Note Amendment and Waiver”) with the holder of the April 2022 Senior

Convertible Note and the September 2022 Senior Convertible Note (each such term as defined below).

Pursuant to the Note Amendment and

Waiver, the maturity date of the April 2022 Senior Convertible Note was extended to April 4, 2025 and the maturity date of the September

2022 Senior Convertible Note was extended to September 8, 2025, in each case subject to further extension in certain circumstances.

holder of the such note also waived, for the period commencing on December 1, 2023 and ending on August 31, 2024, the financial covenant

contained in such notes requiring that the ratio of (a) the outstanding principal amount of the notes, accrued and unpaid interest thereon

and accrued and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days, not exceed

30%, and that the Company’s market capitalization not be less than $75 million.

In consideration of the Note Amendment and Waiver,

the Company agreed to pay the holder of the notes $2,000,000 in cash (or in such other form as may be mutually agreed in writing) by April

our accompanying consolidated financial statements Note 13, Debt , for further discussion of the SPA dated March 31, 2022 and the

senior convertible notes.

Lucid Diagnostics - Preferred Stock Offerings

On March 13, 2024, Lucid entered

into subscription agreements (each, a “Series B Subscription Agreement”) and exchange agreements (each, an “Exchange

Agreement”) with certain accredited investors (collectively, the “Series B Investors”), which agreements provided for

(i) the sale to the Series B Investors of 12,495 shares of Lucid’s newly designated Series B Convertible Preferred Stock, par value

$0.001 per share (the “Lucid Series B Preferred Stock”), at a purchase price of $1,000 per share, and (ii) the exchange by

the Series B Investors of 13,625 shares of Lucid’s Series A Convertible Preferred Stock, par value $0.001 per share (the “Lucid

Series A Preferred Stock”), and 10,670 shares of Lucid’s Series A-1 Convertible Preferred Stock, par value $0.001 per share

(the “Lucid Series A-1 Preferred Stock”), held by them for 31,790 shares of Lucid Series B Preferred Stock (collectively,

the “Lucid Series B Offering and Exchange”).

Prior to the execution of the Series B Subscription Agreements and the Exchange

Agreements, Lucid entered into subscription agreements with certain of the Series B Investors providing for the sale to such investors

of 5,670 shares of Lucid Series A-1 Preferred Stock, at a purchase price of $1,000 per share, which shares the investors immediately agreed

to exchange for shares of Lucid Series B Preferred Stock pursuant to the Exchange Agreements (and are included in the 10,670 shares of

Lucid Series A-1 Preferred Stock set forth above).

Each share of the Lucid Series B Preferred Stock has a stated value of $1,000 and a

conversion price of $1.2444.

The terms of the Lucid Series B Preferred Stock also include a one times preference on liquidation and a

right to receive dividends equal to 20% of the number of shares of Lucid common stock into which such Lucid Series B Preferred Stock is

convertible, payable on the one-year and two-year anniversary of the issuance date.

The Lucid Series B Preferred Stock is a voting security.

The aggregate gross proceeds to Lucid of these transactions was $18.16 million (inclusive of $5.67 million of aggregate gross proceeds

from the sale of the Lucid Series A-1 Preferred Stock that was immediately exchanged for Lucid Series B Preferred Stock in the transactions).

As a result of 100% of the then-outstanding

shares of Lucid Series A Preferred Stock and Lucid Series A-1 Preferred Stock being exchanged for shares of Lucid Series B Preferred Stock

in the Lucid Series B Offering and Exchange, no shares of Lucid Series A Preferred Stock or Lucid Series A-1 Preferred Stock remain outstanding.

On October 17, 2023, Lucid sold

5,000 shares of Lucid Series A-1 Preferred Stock, solely to accredited investors (all of which were including in the 10,670 shares of

Lucid Series A-1 Preferred exchanged for Lucid Series B Preferred Stock in the Lucid Series B Offering and Exchange).

The aggregate gross

proceeds to Lucid of this offering was $5.0 million.

Medicare Coverage

November 2024, Lucid submitted to MolDx its complete clinical evidence package in support of a request for reconsideration of the non-coverage

language in the LCD to secure Medicare coverage for EsoGuard.

The EsoGuard clinical evidence package included six new peer-reviewed publications:

three clinical validation studies (two in the intended use population, one case control), two clinical utility studies, and one analytical

validation study.

The current LCD provides clear coverage criteria consistent with the ACG guidelines

for esophageal precancer testing.

The package was submitted as part of a request for reconsideration of the non-coverage language in

the LCD to secure Medicare coverage for EsoGuard.

NCCN Clinical Practice Guidelines Update

In March 2025, Lucid announced that

a recent update to the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

focused on Esophageal and Esophagogastric Junction Cancers (Version 1.2025) has added a new section on BE screening.

The NCCN Guidelines®

now reference professional society guidelines on BE screening, including the most recent ACG clinical guideline discussed above, which

recommends non-endoscopic biomarker testing, such as EsoGuard performed on samples collected with EsoCheck, as an acceptable alternative

to invasive upper endoscopy to detect esophageal precancer.

Clinical Study Publications

On March 18, 2025, Lucid announced

that its ENVET-BE clinical utility study has been accepted for publication in Gastroenterology & Hepatology—the fifth peer-reviewed

publication of clinical utility data for Lucid’s EsoGuard® Esophageal DNA Test, and the second to present findings from a real-world

screening population.

The manuscript, entitled “Enhancing the Diagnostic Yield of EGD for Diagnosis of Barrett’s Esophagus Through

Methylated DNA Biomarker Triage,” demonstrates that confirmatory upper endoscopy (EGD) performed in EsoGuard-positive patients had

a substantially higher diagnostic yield for detecting esophageal precancer (Barrett’s Esophagus or BE) than the expected yield of screening

EGD alone in at-risk patients.

The ENVET-BE study reviewed real-world data from a cohort of 199 EsoGuard-positive patients who completed

confirmatory EGD.

The overall positive diagnostic yield for BE was 2.4-fold higher than the expected yield of screening EGD alone, based

on disease prevalence within an at-risk population.

The yield was nearly three-fold higher in patients meeting American College of Gastroenterology

(ACG) screening criteria.

On November 7, 2024, Lucid announced that its

manuscript for its multi-center ESOGUARD BE-1 study has been accepted for publication in The American Journal of Gastroenterology,

the official journal of the American College of Gastroenterology (ACG).

This is the fourth publication presenting clinical

validation data for Lucid’s EsoGuard® Esophageal DNA Test, and the second to demonstrate its performance in an

intended-use screening population.

Consistent with previous studies, EsoGuard showed high sensitivity and negative predictive value

in detecting esophageal precancer (Barrett’s Esophagus or BE).

The prospective, multi-center study presented data from a cohort of

patients who met ACG guideline criteria for esophageal precancer screening and underwent non-endoscopic EsoGuard testing followed by

traditional upper endoscopy.

EsoGuard sensitivity and negative predictive value for detecting BE were approximately 88% and 99%,

respectively.

Specificity and positive predictive value were approximately 81% and 30%, respectively.

No serious adverse events were

Reimbursement Approval

March 13, 2025, Lucid announced that Highmark Blue Cross Blue Shield, an independent licensee of the Blue Cross and Blue Shield Association,

has issued a positive coverage policy for non-invasive screening of esophageal precancer and cancer in New York state.

The new policy

will cover EsoGuard in patients who meet established criteria for esophageal precancer testing consistent with professional society guidelines.

NIH Grant Related to EsoGuard and EsoCheck

On February 27, 2025, Lucid announced that principal investigators from CWRU and University Hospitals (“UH”),

were awarded an $8 million National Institutes of Health (“NIH”) R01 grant to conduct a five-year clinical study designed

to evaluate esophageal precancer detection using EsoCheck and EsoGuard among at-risk individuals without symptoms of chronic GERD.

study, “ A Clinical Trial of Cancer Prevention by Biomarker Based Detections of Barrett’s Esophagus and Its Progression ,”

aims to evaluate the effectiveness of EsoCheck and EsoGuard in detecting esophageal precancer (Barrett’s Esophagus or BE) to prevent

esophageal cancer (EAC) within a non-GERD at-risk population.

To accomplish this aim, 800 patients without GERD symptoms who meet the

AGA risk criteria for screening will be recruited across five participating research centers:

University Hospitals, University of Colorado,

Johns Hopkins University, University of North Carolina, and Cleveland Clinic.

October 10, 2024, PAVmed announced that Veris has been awarded a $1.8 million grant from the National Institute on Minority Health and

Health Disparities (NIMHD), an institute of NIH.

The two-year grant will fund research to optimize

and validate the Veris Cancer Care Platform for the needs of medically underserved cancer patients, in partnership with an academic cancer

The research project, “Bridging the Gap:

Enhancing Cancer Care for Underserved Populations with the Veris Health Cancer

Care Platform,” will focus on patients facing language barriers, limited access to technology, and socioeconomic disparities.

to Board Composition

as of September 10, 2024, James L.

Cox, M.D., and Joan B.

Harvey resigned from the Company’s board of directors.

Harvey’s resignation was due to any disagreement with the Company on any matter relating to its operations, policies or

effective as of September 10, 2024, the Company’s board of directors appointed Sundeep Agrawal, M.D.

as a Class B director.

to being appointed to the Company’s board of directors, Dr.

Agrawal had entered into a strategic advisory agreement with the Company

to provide certain M&A advisory services.

Such agreement remains in effect.

Pursuant to the

agreement, Dr.

Agrawal will receive a monthly consulting fee of $3,333.

The agreement is terminable by the Company on 10 days’

written notice.

Except for the foregoing, Dr.

Agrawal has not engaged in any transactions with the Company that are required to be reported

pursuant to Item 404(a) of Regulation S-K.

Agreements with Lucid

August 6, 2024, the Company and Lucid entered into a ninth amendment to the management services agreement between them (“MSA”)

to increase the monthly fee thereunder from $0.83 million per month to $1.05 million per month, effective as of July 1, 2024.

under the terms of our convertible debt (as amended as of January 17, 2025), we are required to elect that these payments be made in cash.

Cancer Care Platform

June 13, 2024, we announced that Veris and a National Cancer Institute-Designated Comprehensive Cancer Center launched a pilot program

and has enrolled the first patients from such center in such program on the Veris Cancer Care Platform.

Common Stock Offering

February 18, 2025, the Company and Veris entered into subscription agreements (each, a “Subscription Agreement”) with certain

accredited investors (collectively, the “Investors”), pursuant to which the Company agreed to sell and the Investors agreed

to purchase (the “Offering”) 2,574,350 shares of the Company’s common stock and pre-funded warrants to purchase 756,734

shares of the Company’s common stock (the “Pre-Funded Warrants”), at a purchase price of $0.7115 per share or warrant

share (as applicable).

In addition, Veris agreed to issue to each Investor approximately 0.2033 shares of Veris’ common stock for

each share or warrant share (as applicable) purchased by such Investor, for an aggregate of 677,143 shares of Veris’ common stock.

On February 21, 2025, the Company consummated the Offering, generating gross proceeds to the Company of $2.37 million.

The proceeds of

the offering will be used to resume development activities related to Veris’ implantable physiological monitor and for general

working capital purposes.

Subscription Agreement contains customary representations, warranties, covenants and indemnities of the Company and the Investors,

as well as a covenant by the Company to provide the Investors with protection against subsequent equity raises by the Company or

Veris at a lower purchase price (solely to the extent the Investors continue to hold the shares issued in the Offering), with such

protection to be effected through the issuance of additional shares of Veris’ common stock.

In addition, the Company (i)

agreed to solicit the affirmative vote of its stockholders by no later than its next meeting of stockholders, which will be held no

later than June 30, 2025, for approval, for the purposes of the rules of The Nasdaq Stock Market LLC (“Nasdaq”), of the issuance of all of the

shares underlying the Pre-Funded Warrants, and to hold additional meetings quarterly thereafter to the extent such approval is not

obtained, (ii) granted the Investors a 100% participation right in future offerings of equity securities of the Company or its

majority-owned subsidiaries, subject to existing participation rights of the Company’s debt holder, and (iii) agreed not to

incur, and not to permit its majority-owned subsidiaries to incur, any indebtedness until August 18, 2026, subject to certain

In accordance with the Subscription Agreement, the Company also entered into a registration rights agreement (the

“Registration Rights Agreement”) with the Investors, pursuant to which the Company agreed to file a registration

statement covering the resale of the shares of the Company’s common stock issued in the Offering, including the shares

underlying the Pre-Funded Warrants.

Pre-Funded Warrants become exercisable upon the receipt of the stockholder approval described above, expire on February 18, 2030, and

have an exercise price of $0.001 per share, subject to adjustment as described below.

The Pre-Funded Warrants may be exercised for cash,

or on a cashless basis.

In the event the Pre-Funded Warrants are exercised on a cashless basis, the holder will be entitled to receive

a number of shares of the Company’s common stock equal to (x) the excess of the market value of the Company’s common stock

over the exercise price, multiplied by (y) the number of shares as to which the Pre-Funded Warrant is being exercised, divided by (z)

the market value of the Company’s common stock.

The exercise price and number and type of securities or other property issuable

on exercise of the Pre-Funded Warrants may be adjusted in certain circumstances, including in the event of a stock split or combination,

stock dividend, or a recapitalization, reorganization, merger or similar transaction.

In addition, a holder of the Pre-Funded Warrants

will be entitled to participate in rights offerings or pro rata distributions by the Company.

However, there will be no adjustment for

issuances of shares of common stock at a price below the exercise price.

lead investor in the Offering also agreed with the Company that it would, with respect to the election of the Company’s directors,

vote its shares of the Company’s common stock (including those exercisable in respect of their Pre-Funded Warrants) in

accordance with the Company’s board’s recommendations.

Nasdaq Compliance with Stockholders’ Equity

Continued Listing Standard

On February 14, 2025, the Company

received a notification letter from the Nasdaq Listing Qualifications Department, stating that the Company had regained compliance with

the Nasdaq continued listing standard under Nasdaq Listing Rule 5550(b)(1), which requires, among other things, that the Company maintain

at least $2.5 million in stockholders’ equity.

As previously disclosed, on March

7, 2024, the Company received a notice from the Nasdaq Listing Qualifications Department stating that, for the prior 30 consecutive business

days (through March 6, 2024), the market value of the Company’s listed securities had been below the minimum of $35 million required

for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2).

The Company did not regain compliance with

the rule during the time period originally allotted under Nasdaq rules.

Accordingly, the Company timely requested a hearing before a Nasdaq

Hearings Panel (the “Panel”), which took place on October 29, 2024.

On November 8, 2024, the Panel granted the Company an

extension, until January 31, 2025, to regain compliance with the Nasdaq continued listing standards under Nasdaq Listing Rule 5550(b)(1),

in lieu of Nasdaq Listing Rule 5550(b)(2).

The Company achieved compliance through (1) the exchange of secured convertible notes with a principal amount outstanding

of $22.3 million for shares of Series C convertible preferred stock, par value $0.001 (the “Series C Preferred Stock”), which

was consummated on January 17, 2025, (2) the issuance of additional shares of Series C Preferred Stock for an aggregate purchase price

of $2.653 million, which was consummated on January 24, 2025, and (3) a reduction in operating expenses as a result of the Company’s

completed deconsolidation of Lucid from its balance sheet, each of which transactions was previously disclosed and is outlined in more

detail below.

As a result, the Company met the terms of the Panel’s decision.

C Preferred Stock Debt Exchange ;

Amendments to September 2022 Convertible Note.

Under a Securities Purchase Agreement

dated March 31, 2022, the Company issued a Senior Secured Convertible Note dated April 4, 2022, referred to herein as the “April

2022 Senior Convertible Note”, and a Senior Secured Convertible Note dated September 8, 2022, referred to herein as the “September

2022 Senior Convertible Note”.

November 15, 2024, the Company entered into an Exchange Agreement (the “Debt Exchange Agreement”) with the holder (the “Holder”)

of the April 2022 Senior Convertible Note and the September 2022 Senior Convertible Note.

The Debt Exchange Agreement provided for the

exchange of $22.3 million in principal amount of the April 2022 Senior Convertible Note and the September 2022 Senior Convertible Note

and interest thereon for 22,347 shares of Series C Preferred Stock.

January 17, 2025, after satisfaction of all conditions to closing the Exchange, the parties consummated the Exchange.

consummation of the Exchange, the April 2022 Senior Convertible Note was satisfied in full, and the outstanding principal balance of

the remaining September 2022 Senior Convertible Note was approximately $6.6 million.

the Debt Exchange Agreement discussed above, effective as of consummation on the Exchange as of January 17, 2025, the Company also

agreed to certain amendments and modifications to the September 2022 Convertible Note, including, without limitation, that the

conversion price thereunder was reset to $1.068;

that the maturity date was extended to December 31, 2025;

that any change of

control or disposition by the Company of its shares of Lucid common stock would require the prior written consent of the Required

Holders (as defined in the September 2022 Convertible Note);

certain other terms and conditions regarding payments under the MSA and

the application of the same (including that all MSA payments from Lucid must be made in cash);

that the Company waives its right to redeem the September 2022 Convertible Note so long as any shares

of Series C Preferred Stock are outstanding;

that the Holder waives, until December 31, 2025, the financial covenants under the

September 2022 Convertible Note requiring that (i) the amount of the Company’s available cash equal or exceed $8.0 million at

all times, (ii) the ratio of (a) the outstanding principal amount of the September 2022 Convertible Note, accrued and unpaid

interest thereon and accrued and unpaid late charges to (b) the Company’s average market capitalization over the prior ten

trading days, not exceed 30%, and (iii) that the Company’s market capitalization shall at no time be less than $75 million;

and that so long as any shares of Series C Preferred Stock remain outstanding, the Holder will be entitled to exchange all, or any

portion, of the September 2022 Convertible Note (including any interest that would accrue thereon through the maturity date thereof)

into shares of Lucid common stock held by the Company, at an exchange price per share of Lucid common stock equal to $0.85 per share

(as adjusted for stock splits, stock dividends, stock combinations, recapitalizations and similar events), subject to certain

beneficial ownership limitations.

The key terms of the Series C Preferred Stock can be found on Exhibit 4.1 to this Form 10-K.

C Preferred Stock Security Purchase Agreement.

On November 20, 2024, the Company entered into a Securities Purchase

Agreement (the “Series C Securities Purchase Agreement”) with the Holder.

The Series C Securities Purchase Agreement

provides for the purchase of 2,653 shares of Series C Preferred Stock at a price of $1,000 per share, with the purchase price to be

satisfied through the cancellation of $2.6 million of certain unsecured debt obligations owed by the Company to the Holder (the

January 24, 2025, after satisfaction of all conditions to closing the Purchase, the parties consummated the Purchase.

Lucid Deconsolidation.

On September 10,

2024, the Company determined that Lucid and its subsidiaries will be deconsolidated from the Company’s financial statements as of

September 10, 2024, as a result of the changes in the composition of the Company’s board of directors discussed above, in combination

with the Company ceasing to have control over a majority of the voting power of Lucid.

As a result of these events, the Company is considered

to cease to have control over Lucid for the purposes of U.S.

generally accepted accounting principles, even though it continues to own,

and has not disposed any of its, 31,302,444 shares of common stock of Lucid.

Nasdaq Notice of Noncompliance

with the Minimum Bid Price Requirement

January 23, 2025, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30

consecutive business days (through January 22, 2025), the closing bid price of the Company’s common stock had been below the

minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).

notification letter stated that the Company would be afforded 180 calendar days (until July 22, 2025) to regain compliance.

to regain compliance, the closing bid price of the Company’s common stock must be at least $1 for a minimum of ten consecutive

business days.

The notification letter also stated that, in the event the Company does not regain compliance within the initial

180-day period, the Company may be eligible for an additional 180-day period.

If the Company is not eligible for the additional

180-day period, or if it appears to the Nasdaq staff that the Company will not be able to cure the deficiency, the Nasdaq Listing

Qualifications Department will provide notice after the end of the initial 180-day period that the Company’s securities will

be subject to delisting.

The Nasdaq notification has no effect at this time on the listing of the Company’s common stock or

Series Z warrants, and the common stock and Series Z warrants will continue to trade uninterrupted under the symbol

“PAVM” and “PAVMZ,” respectively.

Long-Term Incentive Plan

January 2025, the Company accepted from employees the voluntary forfeiture of approximately 494,202 of previously granted Company stock

options, each with an exercise price greater than $4.00 per share and collectively with a weighted average exercise price of $23.38 per

None of the forfeitures were from Section 16 officers or board members.

Share Increase

January 15, 2025, the Company received shareholder approval to amend its certificate of incorporation, as amended, to increase the total

number of shares of common stock the Company is authorized to issue by 200 million shares from 50 million shares to 250 million shares.

An amendment effecting such change was filed with the Secretary of State of Delaware on January 15, 2025.

Diagnostics — Registered Direct Offering

March 5, 2025, Lucid closed on the sale of 13,939,331 shares of its common stock, pursuant to its previously announced offering of shares

of common stock at a price of $1.10 per share (the “Lucid Offering”).

net proceeds of the Lucid Offering, after deducting the estimated placement agent’s fees and other expenses of the Lucid Offering,

was approximately $14.5 million.

Lucid intends to use the net proceeds from the Lucid Offering for working capital and other general

corporate purposes.

connection with the Lucid Offering, Lucid suspended its “at the market offering” program.

In November 2022, Lucid

entered into a Controlled Equity Offering℠ Sales Agreement (the “Lucid Sales Agreement”) with Cantor Fitzgerald

Pursuant to the Sales Agreement, from time to time, Lucid may offer and sell shares of its common

stock to or through Cantor, acting as sales agent or principal.

Sales of Lucid’s common stock by Cantor, if any, under the

Sales Agreement may be made by any method permitted by law and deemed to be an “at the market offering” as defined in

Rule 415(a)(4) promulgated under the Securities Act (the “Lucid ATM Offering”).

Lucid filed a prospectus supplement

dated December 6, 2022 (the “Lucid ATM Prospectus Supplement”), for the offer and sale of shares of its common stock

having an aggregate offering price of up to $6,500,000 in the Lucid ATM Offering.

Effective as of March 4, 2025, Lucid terminated

the Lucid ATM Prospectus Supplement.

Lucid will not make any sales of common stock in the Lucid ATM Offering unless and until a new

prospectus or prospectus supplement is filed.

Other than the termination of the Lucid ATM Prospectus Supplement, the Lucid Sales

Agreement remains in full force and effect.

Diagnostics — Debt Refinancing

November 22, 2024, Lucid closed on the sale of $21.975 million in principal amount of 12.0% Senior Secured Convertible Notes due 2029

(collectively, the “Lucid 2024 Convertible Notes”), in a private placement, to certain accredited investors (the “Lucid

2024 Note Investors”).

The sale of the Lucid 2024 Convertible Notes was completed pursuant to the terms of the previously disclosed

Securities Purchase Agreement, dated as of November 12, 2024 (the “Lucid 2024 SPA”), between Lucid and the Lucid 2024 Note

Lucid realized gross proceeds of $21.95 million and, after giving effect to the repayment in full of the Lucid 2023 Convertible

Note (as defined below), net proceeds of $18.3 million from the sale of the Lucid 2024 Convertible Notes.

used a portion of the proceeds from the sale of the Lucid 2024 Convertible Notes to repay the Senior Convertible Note (the “Lucid

2023 Convertible Note”) issued pursuant to that certain Securities Purchase Agreement, dated as of March 13, 2023.

the terms of the Lucid 2023 Convertible Note, on November 22, 2024, Lucid redeemed the Lucid 2023 Convertible Note by paying the contractual

redemption price of approximately $3.7 million.

December 2021, we entered into an “at-the-market offering” for up to $50 million of our common stock that may be offered

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payment of 3% commissions.

business will depend proprietary medical device and diagnostic technologies to commercialize.

We own or have the right to use intellectual

property rights, such as patents, trademarks, copyrights, trade secrets and know-how, pertaining to our EsoCheck and EsoGuard technology,

our Veris technology and our EsoCure, CarpX and PortIO products, among other technologies and products.

Subsequent to December 31, 2024, as of March 20, 2025, the Company sold 1,210,704 shares through

their at-market equity facility for net proceeds of approximately $0.8 million, after payment of 3% commissions.

business will depend on proprietary medical device and diagnostic technologies to commercialize.

We own or have the right to use

intellectual property rights, such as patents, trademarks, copyrights, trade secrets and know-how, pertaining to our EsoCheck and

EsoGuard technology, our Veris technology and our EsoCure, CarpX and PortIO products, among other technologies and

intend to vigorously protect our proprietary technologies’ intellectual property rights in patents, trademarks and copyrights,

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Each of the technologies noted below is protected by multiple families.

and only the earliest expiration for the first of the families is listed.

The date the patents protecting certain of our owned and licensed

technology will first begin to expire is as set forth in the table below (although currently pending patent applications, both foreign

and domestic, are positioned to provide protection beyond such date in each instance).

For EsoGuard, families are pending that, when

granted, will offer additional protections until at least 2037.

Our policy is to aggressively file patent applications to

protect our proprietary technologies including inventions and improvements to inventions.

We seek patent protection, as appropriate,

The date the patents protecting certain of our owned and licensed technology will first begin to expire is as set forth in the table

below (although currently pending patent applications, both foreign and domestic, provide protection beyond such date in each instance).

For EsoGuard, additional patents have been issued that offer protection until at least 2037.

policy is to aggressively file patent applications to protect our proprietary technologies including inventions and improvements to inventions.

We seek patent protection, as appropriate, on:

product itself including all embodiments with future commercial potential;

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classify our products, nor predict what requirements will be placed upon us to obtain market clearance or approve our products at all.

request marketing authorization by means of a 510(k) clearance, we must submit a pre-market notification demonstrating the proposed device

is substantially equivalent to another currently legally marketed medical device, has the same intended use, and is as safe and effective

as a currently legally marketed device and does not raise different questions of safety and effectiveness than does a currently legally

marketed device.

510(k) submissions generally include, among other things, a description of the device and its manufacturing, device

labeling, medical devices to which the device is substantially equivalent, safety and biocompatibility information, and the results of

performance testing.

In some cases, a 510(k) submission must include data from human clinical studies.

Marketing may commence only when

the FDA issues a clearance letter finding substantial equivalence.

After a device receives 510(k) clearance, any product modification

that could significantly affect the safety or effectiveness of the product, or would constitute a significant change in intended use,

requires a new 510(k) clearance or, if the device would no longer be substantially equivalent, would require PMA, or possibly, a de novo

pathway under section 513(f)2 of the FDCA.

In addition, any additional claims the Company wished to make at a later date may require

If the FDA determines the product does not qualify for 510(k) clearance, they will issue a Not Substantially Equivalent letter,

at which point the Company must submit and the FDA must approve a PMA or issue premarket clearance using the de novo before marketing

request marketing authorization by means of a 510(k) clearance, we must submit a pre-market notification demonstrating the proposed

device is substantially equivalent to another currently legally marketed medical device, has the same intended use, and is as safe

and effective as a currently legally marketed device and does not raise different questions of safety and effectiveness than does a

currently legally marketed device.

510(k) submissions generally include, among other things, a description of the device and its

manufacturing, device labeling, medical devices to which the device is substantially equivalent, safety and biocompatibility

information, and the results of performance testing.

In some cases, a 510(k) submission must include data from human clinical

Marketing may commence only when the FDA issues a clearance letter finding substantial equivalence.

After a device receives

510(k) clearance, any product modification that could significantly affect the safety or effectiveness of the product, or would

constitute a significant change in intended use, requires a new 510(k) clearance or, if the device would no longer be substantially

equivalent, would require PMA, or possibly, a de novo pathway under section 513(f)(2) of the FDCA.

In addition, any additional

claims the Company wished to make at a later date may require a PMA.

If the FDA determines the product does not qualify for 510(k)

clearance, they will issue a Not Substantially Equivalent (“NSE”) letter, at which point the Company must submit and the

FDA must approve a PMA or issue premarket clearance using the de novo before marketing can begin.

1997, the Food and Drug Administration Modernization Act (“FDAMA”) added the de novo classification pathway under section 513(f)(2) of

the FDCA, establishing an alternate pathway to classify new devices into Class I or II that had automatically been placed in

Class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission.

In this process, a sponsor

who receives an NSE determination may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based

classification of the device under section 513(a)(1) of the Act.

2012, section 513(f)(2) of the FDCA was amended by section 607 of the Food and Drug Administration Safety and Innovation Act

(FDASIA), to provide a second option for de novo classification.

In this second pathway, a sponsor who determines there is no legally

marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of

the device under section 513(a)(1) of the Act without first submitting a 510(k).

the FDCA, establishing an alternate pathway to classify new devices into Class I or II that had automatically been placed in Class III

after receiving an NSE determination in response to a 510(k) submission.

In this process, a sponsor who

receives an NSE determination may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification

of the device under section 513(a)(1) of the Act.

2012, section 513(f)(2) of the FDCA was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (“FDASIA”),

to provide a second option for de novo classification.

In this second pathway, a sponsor who determines there is no legally marketed

device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device

under section 513(a)(1) of the Act without first submitting a 510(k).

the review of a 510(k) submission, the FDA may request more information or additional studies and may decide the indications for which

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or more clinical trials may be necessary to support an FDA submission.

Clinical studies of unapproved or uncleared medical devices or

devices being studied for uses for which they are not approved or cleared (investigational devices) must be conducted in compliance with

FDA requirements.

If an investigational device could pose a significant risk to patients, the sponsor company must submit an Investigational

Device Exemption, or IDE application to the FDA prior to initiation of the clinical study.

An IDE application must be supported by appropriate

data, such as animal and laboratory test results, showing it is safe to test the device on humans and the testing protocol is scientifically

The IDE will automatically become effective 30 days after receipt by the FDA unless the FDA notifies the company the investigation

may not begin.

Clinical studies of investigational devices may not begin until an institutional review board (“IRB”) has

approved the study.

Clinical studies of unapproved or uncleared medical devices

or devices being studied for uses for which they are not approved or cleared (investigational devices) must be conducted in

compliance with FDA requirements.

If an investigational device could pose a significant risk to patients, the sponsor company must

submit an Investigational Device Exemption (“IDE”) application to the FDA prior to initiation of the clinical study.

An IDE application

must be supported by appropriate data, such as animal and laboratory test results, showing it is safe to test the device on humans

and the testing protocol is scientifically sound.

The IDE will automatically become effective 30 days after receipt by the FDA

unless the FDA notifies the company the investigation may not begin.

Clinical studies of investigational devices may not begin until

an institutional review board (“IRB”) has approved the study.

any study, the sponsor must comply with the FDA’s IDE requirements.

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implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare professionals.

In any event, we have established

a substantial regulatory and compliance infrastructure that is designed to ensure compliance with these regulations.

any event, we have established a substantial regulatory and compliance infrastructure that is designed to ensure compliance with these

Payment Sunshine Act

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Our failure to comply with these privacy laws or significant changes in the laws restricting

our ability to obtain stool, blood and other patient samples and associated patient information could significantly impact our business

our ability to obtain patient samples and associated patient information could significantly impact our business

and our future business plans.

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FDA clearance, and requirements for licensing a product in a foreign country may differ significantly from FDA requirements.

European Union (“EU”) will require a CE mark certification or approval in order to market our products in the various countries of the

European Union or other countries outside the United States.

To obtain CE mark certification of our products, we will be required to

work with an accredited European notified body organization to determine the appropriate documents required to support certification

European Union (“EU”) will require a CE mark certification or approval in order to market our products in the various countries

of the European Union or other countries outside the United States.

To obtain CE mark certification of our products, we will be required

to work with an accredited European notified body organization to determine the appropriate documents required to support certification

in accordance with existing medical device directive.

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Good Manufacturing Practices

the European Union, the manufacture of medical devices is subject to good manufacturing practice (“GMP”), as set forth in the relevant

laws and guidelines of the European Union and its member states.

Compliance with GMP is generally assessed by the competent regulatory

Typically, quality system evaluation is performed by a Notified Body, which also recommends to the relevant competent authority

for the European Community CE Marking of a device.

The Competent Authority may conduct inspections of relevant facilities, and review

manufacturing procedures, operating systems and personnel qualifications.

In addition to obtaining approval for each product, in many

cases each device manufacturing facility must be audited on a periodic basis by the Notified Body.

Further inspections may occur over

the life of the product.

the European Union, the manufacture of medical devices is subject to good manufacturing practice (“GMP”), as set forth in

the relevant laws and guidelines of the European Union and its member states.

Compliance with GMP is generally assessed by the competent

regulatory authorities.

Typically, quality system evaluation is performed by a Notified Body, which also recommends to the relevant competent

authority for the European Community CE Marking of a device.

The Competent Authority may conduct inspections of relevant facilities,

and review manufacturing procedures, operating systems and personnel qualifications.

In addition to obtaining approval for each product,

in many cases each device manufacturing facility must be audited on a periodic basis by the Notified Body.

Further inspections may occur

over the life of the product.

Safety and Health

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There were no material capital expenditures for environmental control facilities in the years ended December 31, 2024 and

As of March 21, 2024 we had 107 employees (all of whom were full-time employees), inclusive of our executive officers —

our Chairman of the Board of Directors and Chief Executive Officer (“CEO”), our President and Chief Financial Officer (“CFO”),

our Chief Operating Officer (“COO”), our Chief Medical Officer (“CMO”) and our General Counsel and Secretary

(“General Counsel”).

No employees are covered by a collective bargaining agreement.

We consider our relationship with our

employees to be good.

of March 20, 2025 we had 39 employees (all of whom were full-time employees), inclusive of our executive officers — our

Chairman of the Board of Directors and Chief Executive Officer (“CEO”), our President and Chief Financial Officer (“CFO”),

our Chief Operating Officer (“COO”), and our General Counsel and Secretary (“General Counsel”).

are covered by a collective bargaining agreement.

We consider our relationship with our employees to be good.

were incorporated in Delaware on June 26, 2014.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business